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510(k) K203505

DORO QR3 Headrest System (Aluminum) by Pro Med Instruments GmbH — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2021
Date Received
November 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

Other clearances by Pro Med Instruments GmbH

  • K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); D (July 26, 2024)
  • K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
  • K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
  • K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
  • K191979 — DORO QR3 XTom Headholder System (October 22, 2019)

Other clearances for product code HBL

  • K250423 — mb-FIX Cranial Stabilization Systems (November 6, 2025)
  • K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); D (July 26, 2024)
  • K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
  • K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
  • K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
  • K191701 — Arcus Head Fixation Frame (November 15, 2019)
  • K191979 — DORO QR3 XTom Headholder System (October 22, 2019)
  • K163322 — TZ SKULL PIN Adult (February 23, 2017)
  • K142238 — MAYFIELD Skull Clamp (November 24, 2014)
  • K141950 — HFD100 ROCKER ARM ACCESSORY (September 4, 2014)